Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes
1 other identifier
interventional
82
1 country
1
Brief Summary
This study examined whether dietary-induced reductions in lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma affected metabolic profiles in PBMCs and plasma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedJuly 16, 2014
July 1, 2014
5 months
July 14, 2014
July 15, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Lp-PLA2 Activity in Plasma
Change from baseline in Lp-PLA2 at 12 weeks
Lp-PLA2 Activity in PBMC
Change from baseline in Lp-PLA2 at 12 weeks
Secondary Outcomes (1)
PBMC metabolites
Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)
Other Outcomes (1)
LDL particle size
Changes from baseline in LDL particle size at 12 weeks
Study Arms (2)
Refined rice
PLACEBO COMPARATORWhole grains and legumes
EXPERIMENTALInterventions
Subjects in the control group maintained the usual refined-rice diet.
Subjects in the whole-grain group replaced refined rice with a mix of 1/3 legumes, 1/3 barley, and 1/3 wild rice three times per day, and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.
Eligibility Criteria
You may qualify if:
- subjects who had IFG (100≤ fasting glucose \<126 mg/dL)
- or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL)
You may not qualify if:
- current and/or past history of cardiovascular disease including angina
- liver or kidney dysfunction
- thyroid or pituitary disease
- pregnancy or lactation
- taking medications or supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University
Seoul, 120-749, South Korea
Related Publications (1)
Kim M, Song G, Kang M, Yoo HJ, Jeong TS, Lee SH, Lee JH. Replacing carbohydrate with protein and fat in prediabetes or type-2 diabetes: greater effect on metabolites in PBMC than plasma. Nutr Metab (Lond). 2016 Jan 19;13:3. doi: 10.1186/s12986-016-0063-4. eCollection 2016.
PMID: 26788114DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Ho Lee, PhD
Yonsei University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 16, 2014
Study Start
January 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 16, 2014
Record last verified: 2014-07